Class II · Moderate risk
Mupirocin Calcium Cream
Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.
FDA Drug Recalls
14,806 recalls, newest first
Class II · Moderate risk
Bactroban Cream
Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.
Class II · Moderate risk
Bactroban Ointment
Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.
Class II · Moderate risk
Bactroban (mupirocin calcium)
Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.
Class III · Low risk
Ampicillin Capsules
Labeling: Incorrect Or Missing Package Insert: Product is labeled with unapproved labeling.
Class II · Moderate risk
Midazolam HCl Syrup
Presence of Foreign Substance: customer complaint that one unit dose cup contained a small piece of cardboard contaminant.
Class III · Low risk
Methocarbamol Tablets
Presence of Foreign Substance: Presence of hair.
Class II · Moderate risk
DuraPrep Surgical Solution Iodine Povacrylex
Chemical contamination: Product may be contaminated with a toxic compound.
Class I · High risk
KABOOM action strips
Marketed Without An Approved NDA/ANDA: presence of undeclared Sulfoaildenafil.
Class I · High risk
LiDa DAIDAIHUA
Marketed Without An Approved NDA/ANDA: presence of undeclared Sibutramine and Phenolphthalein.
Class III · Low risk
Topicort (desoximetasone)
Failed Impurities/Degradation Specifications: Out of specification results for impurities testing was obtained at the 6 and 9 month time points.
Class II · Moderate risk
Rivastigmine Tartrate Capsules
Failed Dissolution Specifications
Class II · Moderate risk
Hydrochlorothiazide Tablet USP 25 mg
Presence of Foreign Tablet: A pharmacist found a clopidogrel tablet in the 1000-count bottle of hydrochlorothiazide 25 mg tablets.
Class II · Moderate risk
Lisinopril Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Lisinopril Tablets USP
CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.
Class II · Moderate risk
Lisinopril Tablets USP
CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.
Class III · Low risk
Dexmethylphenidate HCl Extended-Release
Failed Dissolution Specifications: Product is being recalled due to out of specification (above specification) result obtained at 6-hour dissolution time point during the 12-month stability testing.
Class III · Low risk
Hydralazine Hydrochloride Injection
Incorrect Expiration Date: The "11/06" expiration date printed on the tray (secondary packaging) is incorrect (it should be 11/2016)
Class III · Low risk
Meijer Loratadine Orally Disintegrating Tablets
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class III · Low risk
Wal-itin Loratadine Orally Disintegrating Tablets
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class III · Low risk
Sunmark loratadine Orally Disintegrating Tablets
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class III · Low risk
Up&Up loratadine orally disintegrating tablets
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class III · Low risk
TopCare LORATIDINE ORALLY DISINTEGRATING TABLETS
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class III · Low risk
Safeway Care Loratadine Orally Disintegrating Tablets
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class III · Low risk
Premier Value Loratadine Orally Disintegrating Tablets
Superpotent Drug: Out Of Specification (OOS) result for Assay.